Frontotemporal DementiaReRescuePGRNCT02999282
Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects
A study testing Anodal transcranial direct current stimulation in people with Frontotemporal Dementia and GRN Related Frontotemporal Dementia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontotemporal Dementia, GRN Related Frontotemporal Dementia
- What is being tested?
- Anodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass documented by MRI.
- History of traumatic brain injury or other neurological diseases.
- Serious medical illness other than FTD
- History of seizures
- Pregnancy
- Metal implants in the head (except dental fillings)
- Electronic implants (i.e. pace-maker, implanted medical pump)
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitative Trial for the Recovery of Neurophysiological Parameters in Progranulin Mutation Carriers Through the Use of Transcranial Direct Current Stimulation (tDCS)
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia.
Read the detailed description
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia.
All patients will undergo genetic screening for progranulin mutations, a baseline neuropsychological and neurophysiological evaluation, including assessment of short interval intracortical inhibition, intracortical facilitation, short interval intracortical facilitation and long interval intracortical inhibition. Subjects will then be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal frontal and prefrontal anodal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a neuropsychological and neurophysiological evaluation at 2 weeks, 1 month (only neurophysiological evaluation), 3 months and 6 month after treatment.
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- TMS, tDCS, Rehabilitation
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)
Sham transcranial direct current stimulationDevice
10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Presymptomatic real tDCS | Experimental | Asymptomatic subjects - 10 days anodal transcranial direct current stimulation Receives: Device: Anodal transcranial direct current stimulation |
| Presymptomatic sham tDCS | Sham comparator | Asymptomatic subjects - 10 days sham transcranial direct current stimulation Receives: Device: Sham transcranial direct current stimulation |
| Symptomatic real tDCS | Experimental | Symptomatic patients - 10 days anodal transcranial direct current stimulation Receives: Device: Anodal transcranial direct current stimulation |
| Symptomatic sham tDCS | Sham comparator | Symptomatic patients - 10 days sham transcranial direct current stimulation Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SICI measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)
Measured: Baseline - 2 weeks
Change in ICF measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).
Measured: Baseline - 2 weeks
Secondary outcomes (16)
Change in SICI measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)
Measured: Baseline - 1 month - 3 months - 6 months
Change in ICF measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).
Measured: Baseline - 1 month - 3 months - 6 months
Change in LICI measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on long interval intracortical inhibition (LICI).
Measured: Baseline - 1 month - 3 months - 6 months
Change in SICF measurements from Baseline
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical facilitation (SICF).
Measured: Baseline - 1 month - 3 months - 6 months
Change in MMSE scores from Baseline
The Mini Mental State Examination (MMMSE) is a 30-point questionnaire that is used to measure cognitive impairment.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in phonemic fluencies scores from Baseline
Produce as many words as possible beginning with a specified letter in 60 seconds
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in semantic fluencies scores from Baseline
Produce as many words as possible from a category in 60 seconds
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in digit span forward scores from Baseline
Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in digit span backward scores from Baseline
Participants hear a sequence of numerical digits and are tasked to recall the sequence correctly in reverse order, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in camel and cactus test scores from Baseline
Evaluates associative semantic memory with 64 items presented for naming and word-picture matching.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in TMTA scores from Baseline
The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper to examine cognitive processing speed.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in TMTB scores from Baseline
The task requires a subject to connect a sequence of 25 consecutive targets on a sheet of paper, alternating between numbers and letters, to examine executive functioning.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in Stroop test scores from Baseline
Measure a person's selective attention capacity and skills, as well as their processing speed ability.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in Symbol Digit test scores from Baseline
It consists of digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in Block Design test scores from Baseline
To evaluated spatial visualization ability and motor skills. The test-taker uses hand movements to rearrange blocks that have various color patterns on different sides to match a pattern. The items in a block design test are scored both by accuracy in matching the pattern and by speed in completing each item.
Measured: Baseline - 2 weeks - 3 months - 6 months
Change in The modified EkmanFaces Test from Baseline
Each face is presented on a sheet with six labels of basic emotions below the photograph. The patient was required to respond verbally, deciding the label that best described the facial expression shown.
Measured: Baseline - 2 weeks - 3 months - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start31 Oct 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Borroni, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Barbara Borroni, MD, Principal investigator, Azienda Ospedaliera Spedali Civili, BresciaAlberto Benussi, MD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999282
- Sponsor's protocol ID
- NP2441
- Acronym
- ReRescuePGR
- Status last verified
- Mar 2020
- First submitted
- 2 Dec 2016
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data, including outcome measure results, study protocol and statistical analysis plan, will be shared.
Publications
Benussi A, Cosseddu M, Filareto I, Dell'Era V, Archetti S, Sofia Cotelli M, Micheli A, Padovani A, Borroni B. Impaired long-term potentiation-like cortical plasticity in presymptomatic genetic frontotemporal dementia. Ann Neurol. 2016 Sep;80(3):472-6. doi: 10.1002/ana.24731. Epub 2016 Aug 10.
PubMed 27438089Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PubMed 27372845Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
PubMed 25797650
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Trial for the Recovery of Neurophysiological Parameters in Progranulin Mutation Carriers Through the Use of Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT02999282
- Acronym / sponsor ID
- ReRescuePGR / NP2441
- Keywords
- TMS, tDCS, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia.
Detailed description
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects bearing a pathogenic GRN mutation and in symptomatic patients with frontotemporal dementia.
All patients will undergo genetic screening for progranulin mutations, a baseline neuropsychological and neurophysiological evaluation, including assessment of short interval intracortical inhibition, intracortical facilitation, short interval intracortical facilitation and long interval intracortical inhibition. Subjects will then be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal frontal and prefrontal anodal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a neuropsychological and neurophysiological evaluation at 2 weeks, 1 month (only neurophysiological evaluation), 3 months and 6 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Presymptomatic real tDCS | Experimental | Device: Anodal transcranial direct current stimulationAsymptomatic subjects - 10 days anodal transcranial direct current stimulation |
| Presymptomatic sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulationAsymptomatic subjects - 10 days sham transcranial direct current stimulation |
| Symptomatic real tDCS | Experimental | Device: Anodal transcranial direct current stimulationSymptomatic patients - 10 days anodal transcranial direct current stimulation |
| Symptomatic sham tDCS | Sham comparator | Device: Sham transcranial direct current stimulationSymptomatic patients - 10 days sham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass documented by MRI.
- History of traumatic brain injury or other neurological diseases.
- Serious medical illness other than FTD
- History of seizures
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulation10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks) | Device | Presymptomatic real tDCS, Symptomatic real tDCS |
| Sham transcranial direct current stimulation10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks) | Device | Presymptomatic sham tDCS, Symptomatic sham tDCS |
Primary outcome
Change in SICI measurements from Baseline
Time frame: Baseline - 2 weeks
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)
Change in ICF measurements from Baseline
Time frame: Baseline - 2 weeks
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).
16 secondary outcomes
Change in SICI measurements from Baseline
Time frame: Baseline - 1 month - 3 months - 6 months
Change in ICF measurements from Baseline
Time frame: Baseline - 1 month - 3 months - 6 months
Change in LICI measurements from Baseline
Time frame: Baseline - 1 month - 3 months - 6 months
Change in SICF measurements from Baseline
Time frame: Baseline - 1 month - 3 months - 6 months
Change in MMSE scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in phonemic fluencies scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in semantic fluencies scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in digit span forward scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in digit span backward scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in camel and cactus test scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in TMTA scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in TMTB scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in Stroop test scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in Symbol Digit test scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in Block Design test scores from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Change in The modified EkmanFaces Test from Baseline
Time frame: Baseline - 2 weeks - 3 months - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 27438089Benussi A, Cosseddu M, Filareto I, Dell'Era V, Archetti S, Sofia Cotelli M, Micheli A, Padovani A, Borroni B. Impaired long-term potentiation-like cortical plasticity in presymptomatic genetic frontotemporal dementia. Ann Neurol. 2016 Sep;80(3):472-6. doi: 10.1002/ana.24731. Epub 2016 Aug 10.
- Background: PubMed 27372845Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Background: PubMed 25797650Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
- Individual participant dataSharing planned: Yes. All data, including outcome measure results, study protocol and statistical analysis plan, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Borroni, MD principal investigator
Azienda Ospedaliera Spedali Civili, Brescia
Alberto Benussi, MD principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation in people with Frontotemporal Dementia and GRN Related Frontotemporal Dementia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SICI measurements from Baseline (time frame: Baseline - 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.